colorectal cancer
Conditions
Interventions
Trial group:Trifluridine/tipiracil tablets (25 mg/m^2 twice daily, BID) are administered orally within 1 hour after morning and evening meals on Days 1-5, repeated every 2 weeks
bevacizumab 5 mg/kg is administered intravenously on Day 1, repeated every 14 days
tislelizumab 200 mg per dose is administered by intravenous infusion on Day 1 of each cycle, with a 3-week treatment cycle. The treatment continues until disease progression, death, or withdrawal of i
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Has provided written informed consent; 2. Age >=18 years; 3. Histologically confirmed colorectal cancer; 4. Locally advanced unresectable or metastatic disease confirmed by imaging; 5. Must have received at least second-line or higher standard therapy including fluoropyrimidine, oxaliplatin, or irinotecan, with treatment failure defined as disease progression or intolerable toxicity during treatment or within 3 months after the last treatment: (1) Each line of therapy must include one or more chemotherapeutic agents administered for >=1 cycle; (2) Prior adjuvant or neoadjuvant therapy is allowed. If recurrence or metastasis occurs during or within 6 months after adjuvant/neoadjuvant therapy, the adjuvant/neoadjuvant therapy is considered first-line treatment for advanced disease; (3) Prior use of chemotherapy combined with cetuximab or bevacizumab is permitted; 6. Must have at least one measurable lesion per RECIST 1.1 criteria: spiral CT measurement of longest diameter >=10 mm or conventional CT measurement >=20 mm; 7. ECOG performance status 0-1; 8. Expected survival >=12 weeks; 9. No prior treatment with VEGFR inhibitors (TKIs) or PD-1/PD-L1 inhibitors; 10. Within 7 days prior to enrollment, organ function must meet the following criteria (no blood products or growth factors administered within 14 days prior to enrollment): (1) Absolute neutrophil count (ANC) >=1.5 × 10^9/L; (2) Platelet count (PLT) >=100 × 10^9/L; (3) Hemoglobin (HGB) >=8.0 g/dL; (4) Total bilirubin 50 mL/min; 11. Women of childbearing potential must use effective contraception; 12. Good compliance and willingness to participate in follow-up.
Exclusion criteria
Exclusion criteria: 1. Unable to comply with the study protocol or procedures; 2. Prior treatment with PD-1 or PD-L1 inhibitors; 3. Participation in another drug clinical trial within 4 weeks prior to enrollment; 4. Received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, hormone therapy, or immunotherapy, within 2 weeks prior to enrollment; 5. Clinically significant electrolyte abnormalities as judged by the investigator; 6. Unresolved toxicity grade >1 by CTCAE v5.0 due to prior anti-tumor therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity 2; 14. Ventricular arrhythmia requiring pharmacological treatment; 15. LVEF =1×10^4 copies/mL or >2000 IU/ml regardless of prior treatment); 18. Pregnancy (positive pregnancy test prior to dosing) or breastfeeding; 19. Use of immunosuppressive drugs within 4 weeks prior to first dose of treatment, excluding intranasal, inhaled, or topical corticosteroids or physiological dose systemic corticosteroids (i.e., <=10 mg/day prednisone or equivalent), or steroids for contrast allergy prophylaxis; 20. Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dose of treatment or anticipated major surgery during the study; laparoscopic exploration within 2 weeks prior to first dose of trial treatment; 21. Known symptomatic central nervous system metastases and/or carcinomatous meningitis. For previously treated brain metastases, if disease is stable (no radiological progression evidence at least 4 weeks prior to first dose, confirmed by repeat imaging showing no new lesions or enlargement of existing lesions) and not requiring steroids for at least 14 days prior to first dose, participation is allowed. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability; 22. Clinically detectable ascites, or ascites requiring treatment (past or current); only asymptomatic minimal ascites on imaging is permitted; 23. Bilateral moderate pleural effusion, unilateral large pleural effusion, or pleural effusion causing respirator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate(ORR);Disease control rates(DCR);Overall survival(OS);Safety;Quality of Life Questionnaire (QLQ-C30); | — |
Countries
China
Contacts
Public ContactLiu Yibing
The Fourth Hospital of Hebei Medical University
Outcome results
None listed